What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly those involving EGFR-targeting agents like AFM24 and PD-L1 inhibitors like Atezolizumab, have distinct side effect profiles. EGFR-targeting agents often cause diarrhea, rash, nausea, and dry skin. PD-L1 inhibitors are associated with immune-related adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. While severe adverse effects can occur, they are less common.

What prior FDA approvals exist?

FDA-approved treatments for solid tumors include EGFR-targeting agents such as Cetuximab and Erlotinib, which are used in cancers like colorectal cancer and non-small cell lung cancer (NSCLC). Atezolizumab, a PD-L1 inhibitor, has received approval for multiple indications, including NSCLC, urothelial carcinoma, and triple-negative breast cancer. These approvals highlight the therapeutic potential of targeting both EGFR and PD-L1 pathways to improve treatment outcomes in solid tumors.

What other types of research exist?

Promising alternatives to AFM24 and Atezolizumab for solid tumors include: 1) Cetuximab, an EGFR inhibitor, which can be combined with T-cell mediated cytotoxicity to enhance efficacy. 2) Pembrolizumab and Nivolumab, both PD-1 inhibitors, which have shown effectiveness in various solid tumors. 3) Novel combinations such as EGFR inhibitors with immunotherapies or other targeted agents, as ongoing research and clinical trials continue to explore these options.

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Monoclonal Antibodies

AFM24 + Atezolizumab for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Affimed GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed advanced or metastatic EGFR-positive selected cancer types: Advanced or metastatic NSCLC, EGFR WT: disease has progressed after ≥ 1 prior lines of therapy which must have included a platinum-based doublet in combination with PD1/PD-L1 antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet

Advanced, unresectable, or metastatic gastric/GEJ adenocarinoma: after ≥ 1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet

Must not have

Treatment with systemic anticancer therapy including investigational agent within 4 weeks of the first dose of study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during cycle 1 (each cycle has 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing AFM24 with atezolizumab in patients with advanced cancers that have not responded to other treatments. The treatment works by helping the immune system recognize and attack cancer cells. Atezolizumab is used in various advanced cancers, including lung and breast cancer.

Who is the study for?

This trial is for adults with advanced or metastatic EGFR-positive cancers, like NSCLC, gastric/GEJ adenocarcinoma, HCC, hepatobiliary-, or pancreatic cancer that's worsened after treatment. They must have had certain prior therapies and good organ function. People can't join if they've had recent radiation therapy, active malignancies (with some exceptions), recent anticancer treatments, are using traditional Chinese medicine for tumors, or are in another clinical study.

What is being tested?

The AFM24-102 study tests the combination of a new drug called AFM24 with an existing cancer medication Atezolizumab in patients with specific advanced solid tumors expressing EGFR. It's an open-label Phase 1/2a trial where all participants receive the drugs to evaluate safety and effectiveness at different doses.

What are the potential side effects?

Possible side effects include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation of organs (like lungs or intestines), hormonal gland problems (like thyroid issues), liver problems and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is EGFR-positive and has worsened after treatment including platinum and PD1/PD-L1 therapy.

Select...

My stomach cancer is advanced and I've had at least one chemo treatment including platinum and fluoropyrimidine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken any cancer drugs or traditional Chinese medicine for cancer in the last 2 to 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during cycle 1 (each cycle has 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during cycle 1 (each cycle has 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during cycle 1 (each cycle has 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Incidence of dose limiting toxicities (DLTs) during Cycle 1

Phase 2a: Overall Response Rate (complete response [CR] + partial response [PR])

Secondary study objectives

Frequency of patients developing anti-drug antibodies (ADAs) against AFM24

Incidence of TEAEs and SAEs

Pharmacokinetics (PK) of AFM24

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion PhaseExperimental Treatment2 Interventions

The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab.

Group II: Escalation PhaseExperimental Treatment2 Interventions

The Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab 840 MG in 14 ML Injection

2021

Completed Phase 2

~420

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

EGFR-targeting agents inhibit the epidermal growth factor receptor, preventing tumor cell proliferation and survival by blocking key signaling pathways. PD-L1 inhibitors like Atezolizumab enhance the immune system's ability to recognize and destroy cancer cells by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells. These targeted treatments are crucial for solid tumor patients as they disrupt tumor growth and boost immune response, potentially improving treatment outcomes.

Antimetastatic activities and mechanisms of bisdioxopiperazine compounds.